The following data is part of a premarket notification filed by Iogyn, Inc. with the FDA for Iogyn System.
| Device ID | K141848 |
| 510k Number | K141848 |
| Device Name: | IOGYN SYSTEM |
| Classification | Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar |
| Applicant | IOGYN, INC. 20195 STEVENS CREEK BOULEVARD SUITE 120 Cupertino, CA 95014 |
| Contact | Rich Christensen |
| Correspondent | Rich Christensen IOGYN, INC. 20195 STEVENS CREEK BOULEVARD SUITE 120 Cupertino, CA 95014 |
| Product Code | PGT |
| CFR Regulation Number | 884.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-09 |
| Decision Date | 2014-08-29 |
| Summary: | summary |